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Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

Healthcare Biotechnology
Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. The Company’s primary focus is to advance its programs in hormone receptor-positive / human epidermal growth factor 2- negative (HR+/HER2-) metastatic breast cancer and advanced/metastatic pancreatic ductal adenocarcinoma to registration-enabling clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.


TSX:ONC - Post by User

Oncolytics Biotech Inc > FDA's Head of CBER wants faster approvals with SE/biomarkers
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Comment by Noteableon Aug 17, 2023 11:08am
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Post# 35592897

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA's Head of CBER wants faster approvals with SE/biomarkers

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA's Head of CBER wants faster approvals with SE/biomarkersBluebird Bio’s BLA filing is an example of the FDA's decision to speed-up the FDA's approval process by eliminating uncessary FDA drug review meetings.

Aug 16, 2023 

The FDA has indicated that it does not intend to hold an advisory committee meeting for bluebird bio’s investigational gene therapy lovotibeglogene autotemcel (lovo-cel), being developed for sickle cell disease, the company announced Wednesday.

Lovo-cel’s Biologics License Application (BLA) is undergoing regulatory review and the FDA is set to release its decision by Dec. 20.

https://www.biospace.com/article/bluebird-s-lovo-cel-gene-therapy-for-scd-will-not-face-fda-adcomm/


 
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